NHLBI Recipient Epidemiology Donor Evaluation Study (REDS)-III - Red Blood Cell Omics (RBC-Omics) Study

The Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) is an initiative launched by the National Heart, Lung, and Blood Institute (NHLBI) with the goal to improve transfusion medicine practice, ensure safety and reduce risks. Extensive variation exists in donor iron metabolism, hemoglobin production, and hemolysis. Despite this variation, current blood banking guidelines regulating blood donation frequency, donation volume, and storage time and conditions remain uniform for all donors. The RBC-Omics study proposed to investigate if this approach is appropriate. Specifically, the RBC-Omics study: Established a multi-ethnic cohort of blood donors with well-characterized demographic, behavioral, and donation history. Developed a database linking donations from these blood donors to outcomes in transfusion recipients. Identify genetic factors impacting hemoglobin, donation history, ferritin, and iron metabolism. Identify markers and clinical factors associated with the iron-related disorders pica and restless leg syndrome (RLS). Define the genetic and metabolic basis for donor-specific differences in spontaneous, osmotic and oxidative hemolysis at the end of storage. RBC-Omics study has 13,403 blood donors over the age of 18 that were recruited from December 2013 to December 2015 at four REDS-III blood centers: the American Red Cross (Farmington, CT), the Institute for Transfusion Medicine (ITxM, Pittsburgh, PA), Blood Center of Wisconsin (Milwaukee, WI), and the Blood Centers of the Pacific (San Francisco, CA). All blood donors are healthy volunteers who passed donation screening and were not anemic. The samples were genotyped with a customized Affymetrix Axiom array called the TM-Array. The TM-array was specifically designed to cover genetic variations related to transfusion medicine. Also copy number polymorphisms in the alpha globin, beta globin and Rh gene clusters were added. The genetic variations among different ethnicity groups were considered as well.]]>
Inclusion Criteria Participants were men and women 18 and older who successfully donated a red blood cell unit or more equivalent at one of the four REDS-III blood centers. Enrollment strategies were designed to be integrated into routine blood center procedures through the training of blood center registration, collections, and laboratory staff. All blood centers pursued targeted enrollment strategies to increase recruitment of minority (African American and Asian) and White "High Intensity" donors (those who had provided 9 or more red-cell-equivalent donations - double reds qualify as two - in the preceding 24-month period, excluding the enrollment donation, without a low hemoglobin deferral). Enrollment began in December 2013 and was conducted over a 22-month period ending in October 2015. Donors had to make a successful red blood cell donation. Donors needed to meet blood donation criteria which include: weigh at least 110 lbs, were in good health and feeling well, females must have a fingerstick hemoglobin > 12.5 g/dl and males > 13.0 g/dl. Exclusion Criteria Have tested positive for hepatitis B or hepatitis C, lived with or had sexual contact in the past 12 months with anyone who has hepatitis B or symptomatic hepatitis C. Had a tattoo in the past 12 months or received a blood transfusion (except with your own blood) in the past 12 months. Have ever had a positive test for the AIDS virus. Are a man who has had sex with another man in the past 12 months. Have ever used intravenous illegal drugs, even once. Have ever used injectable drugs, including anabolic steroids, unless prescribed by a physician. Have engaged in prostitution since 1977. Have lived in or visited the United Kingdom for three months or more cumulatively between 1980 and 1996. Have spent five years or more in Europe (including the United Kingdom) cumulatively from 1980 to the present. Have traveled in the past year, or lived in the past three years, in an area where malaria is endemic. Indication of IV drug use. Disease such as hemochromatosis, sickle cell disease Elevated and depressed blood pressure. Cancers with certain time limits ]]>